MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. PRONTO AIR PT BASE ONLY 9153653433; WHEELCHAIR, POWERED

Model Number AIRPTMBDY18

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2015

Event Type  malfunction  

Event Description

Dealer states that the end user believes the chair is too wobbly now.Dealer does not believe there is anything wrong but end user thinks the seat is coming too far forward when they stop.End user advised almost caused her to fall out the chair, but has not.Dealer advised no injury.The dealer believes its a balance issue.

Manufacturer Narrative

Should additional information become available, a supplemental record will be filed.

• Brand Name: PRONTO AIR PT BASE ONLY 9153653433
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 2151 21; CH 215121
• Manufacturer (Section G): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 2151 21; CH 215121
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4909048
• MDR Text Key: 6833473
• Report Number: 3008262382-2015-01485
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AIRPTMBDY18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other